Prescription drug · NDA
Topamax (Topiramate) NDC 50458-639
Topiramate 25 mg/1 · Tablet, Coated · Oral · Janssen Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50458-639-65 | 50458063965 | 60 TABLET, COATED in 1 BOTTLE (50458-639-65)Marketed from Jan 1, 1997 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Topamax
- Generic name (nonproprietary)
- topiramate
- Active ingredients
- Topiramate — 25 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Labeler
- Janssen Pharmaceuticals, Inc.NDC labeler code 50458
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020505
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C19 Inhibitors (Mechanism)Cytochrome P450 3A4 Inducers (Mechanism)Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 50458-639_1c7483cf-95db-4b1c-ae4c-b11bc95a6ad8SPL ID 1c7483cf-95db-4b1c-ae4c-b11bc95a6ad8SPL set ID 21628112-0c47-11df-95b3-498d55d89593RxCUI 151226, 151227, 151228, 151229, 152855, 199888, 199889, 199890, 205315, 205316, 845478, 845479UNII 0H73WJJ391UPC 0350458647655, 0350458641653, 0350458645651, 0350458639650, 0350458640656, 0350458642650
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N450458063965followed by a unit qualifier and the quantityPackage 50458-0639-65. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
TOPAMAX is indicated for: Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older ( 1.1 ); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older ( 1.2 ) Preventive treatment of migraine in patients 12 years of age and older ( 1.3 ) 1.1 Monotherapy Epilepsy TOPAMAX is indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older. 1.2 Adjunctive Therapy Epilepsy TOPAMAX is indic…
Excerpt only. Read the full label for complete information.
About NDC 50458-639
- What is NDC 50458-639?
- 50458-639 is the product NDC for Topamax (topiramate), Topiramate 25 mg/1 tablet, coated, listed with the FDA by Janssen Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Topamax (Topiramate).
- What is the active ingredient?
- Topiramate.
- Who is the labeler?
- Janssen Pharmaceuticals, Inc., NDC labeler code 50458. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Topamax?
- 5 other product NDCs are listed under this name. See all Topamax NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Topamax products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Topamaxtopiramate | Topiramate 25 mg/1 | Capsule, Coated pelletsOral | Janssen Pharmaceuticals, Inc. | 50458-645 | 50458-0645-65 |
| Topamaxtopiramate | Topiramate 15 mg/1 | Capsule, Coated pelletsOral | Janssen Pharmaceuticals, Inc. | 50458-647 | 50458-0647-65 |
| Topamaxtopiramate | Topiramate 200 mg/1 | Tablet, CoatedOral | Janssen Pharmaceuticals, Inc. | 50458-642 | 50458-0642-65 |
| Topamaxtopiramate | Topiramate 50 mg/1 | Tablet, CoatedOral | Janssen Pharmaceuticals, Inc. | 50458-640 | 50458-0640-65 |
| Topamaxtopiramate | Topiramate 100 mg/1 | Tablet, CoatedOral | Janssen Pharmaceuticals, Inc. | 50458-641 | 50458-0641-65 |
Other NDCs under NDA 020505
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Topamaxtopiramate | Topiramate 200 mg/1 | Tablet, CoatedOral | Janssen Pharmaceuticals, Inc. | 50458-642 |
| Topamaxtopiramate | Topiramate 50 mg/1 | Tablet, CoatedOral | Janssen Pharmaceuticals, Inc. | 50458-640 |
| Topamaxtopiramate | Topiramate 100 mg/1 | Tablet, CoatedOral | Janssen Pharmaceuticals, Inc. | 50458-641 |